SkyePharma asthma drug may be delayed

(Reuters) - SkyePharma said the extra clinical work could delay the filing of Flutiform with the U.S. Food and Drug Administration until the second half of 2008 and could cost 3 million to 5 million pounds .




"We're talking to the FDA about how to address the particular point they've raised and it's going to depend on exactly what sort of clinical data they might need," Chief Operating Officer Ken Cunningham told Reuters.


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UPDATE 1-US FDA scientist urges taking Avandia off market

(Reuters) - Graham, in slides prepared for his remarks to an advisory
panel, said Avandia increases the risk of cardiovascular
problems such as heart attacks while rival drug Actos, made by
Takeda Pharmaceutical Co. Ltd. , does not.




Senior FDA officials say they do not know if Avandia, known
generically as rosiglitazone, increases heart-attack risk and
are asking the advisory panel if the drug should come off the
market or stay with stronger warnings or limits. Panel
recommendations are expected on Monday afternoon.


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US senators: FDA pulled reviewer off Glaxo drug

(Reuters) - The scientist has believed since 2005 that there was enough
evidence for a strong "black box" warning on Avandia about a
risk of congestive heart failure, the senators said.




In a statement titled "Senators reveal effort by the FDA to
suppress scientific dissent and downplay safety concerns"
released with their letter, they said the reviewer was
"sidelined after voicing safety concerns" about Avandia.


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UPDATE 1-FDA approves J&J test for breast cancer spread

(Reuters) - The test, called the GeneSearch Breast Lymph Node Assay, is
manufactured by Johnson & Johnson unit Veridex LLC.




The molecular-based laboratory test was approved by the FDA
to find cancerous growths in lymph node tissue removed from
breast cancer patients. The aim is to help doctors quickly
decide whether to remove more nodes during surgery, or risk
having the patient undergo a second operation.


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Lilly ads for dog drug misleading, U.S. FDA says

(Reuters) - Lilly's materials touted the percentage of dogs that improved with Reconcile compared with a placebo, but failed to mention that both groups received behavior modification training, the FDA letter said. The promotions "suggest that the product is more effective than has been demonstrated," the FDA said.



The materials also did not mention that some dogs improved with the behavioral training alone, according to the FDA.


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FDA warns of new risks to babies with Roche drug

(Reuters) - The FDA reported the new warning on the "MedWatch" section of its Web site on Thursday. Also posted is a letter to doctors dated June 2007 describing the drug's updated prescribing information.




A spokesman for Roche USA was not available for comment.


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Momenta sees longer US review for generic Lovenox

(Reuters) - In a new filing, the company said the review will "likely
extend" beyond its prior view "due to a change in the projected
timing of certain activities required for the completion of the
FDA's review."




Momenta declined to provide a new projection for the timing
but said it believes the FDA review "continues to progress
satisfactorily."



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US panel backs CryoCor heart flutter device

(Reuters) - The panel urged FDA to request a post-approval study
comparing all patients treated with the CryoCor device and an
alternative treatment, Riley said.




The CryoCor product applies extreme cold via a catheter to
block electrical conduction in heart tissue. The company is
seeking FDA approval to sell the device for treating atrial
flutter, an abnormal beating of the heart's upper chambers.


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Congress to press FDA over drug safety woes

(Reuters) - Lawmakers will examine this week how the FDA and manufacturer GlaxoSmithKline Plc handled data that suggested the pill Avandia might raise the chances of having a heart attack.




The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are using the Avandia case to try to build support for tougher safeguards.


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US FDA sets July 30 panel on Glaxo diabetes drug

(Reuters) - Questions about Avandia erupted in May when the New England
Journal of Medicine published an analysis that said the widely
used drug raised heart-attack risk by 43 percent. The FDA and
Glaxo say other evidence conflicts with the finding, and the
agency is weighing whether any regulatory action is needed.




The advisory panel will discuss the cardiovascular risks of
the class known as thiazolidinediones, "with a focus on
rosiglitazone, as presented by FDA and GlaxoSmithKline," the
FDA said. Rosiglitazone is the generic name of Avandia.


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Acorda Therapeutics says FDA agrees on MS drug trial design

(Reuters) - The FDA agreed that this trial, together with the company's
first late-stage trial, would be adequate to support a New Drug
Application for the drug, Acorda said in a statement.





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FDA reviewing risks of Glaxo drug

(Reuters) - A study published in the New England Journal of Medicine said Avandia increased the risk of cardiac-related deaths by 64 percent and heart attacks by 43 percent. Dr. Robert Meyer, head of the FDA office that reviews diabetes drugs, said other data contradicted those findings.




"FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies," Meyer told reporters during a conference call.


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CORRECTED: FDA reviewing risks of Glaxo diabetes drug

(Reuters) - WASHINGTON - U.S. regulators are reviewing the safety of GlaxoSmithKline's Plc's diabetes drug Avandia but have not yet determined the significance of risks reported in a study released on Monday, a U.S. Food and Drug Administration official said.




A study published in the New England Journal of Medicine said Avandia increased the risk of cardiac-related deaths by 64 percent and heart attacks by 43 percent. Dr. Robert Meyer, head of the FDA office that reviews diabetes drugs, said other data contradicted those findings.


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